Brief Summary

This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. WSD0922-FU is a targeted treatment which blocks EGFR. It is able to get into the brain and spinal cord and help treat those types of tumors. Adding WSD0922-FU to the usual treatment with temozolomide may be more effective in slowing disease progression, compared to temozolomide alone, in patients with EGFR-mutant, IDH-wildtype glioblastoma.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

121mo left

Started Aug 2026

Longer than P75 for phase_2

Geographic Reach

1 country

3 active sites

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 years study duration

First Submitted

Initial submission to the registry

July 13, 2026

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed

1 month until next milestone

Study Start

First participant enrolled

August 16, 2026

Expected

10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2036

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2036

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

10 years

First QC Date

July 13, 2026

Last Update Submit

July 21, 2026

Conditions

Glioblastoma, IDH-Wildtype

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS)
Defined as the time from randomization to the time of documented disease progression or death. PFS will be evaluated for each arm, where patients will be evaluated based on the treatment arm to which they were randomized and will include only those who are eligible and have received any protocol therapy to be considered evaluable. PFS distributions will be graphically and quantitatively compared using Kaplan-Meier methods. These methods will be used to estimate the median PFS as well as 1-year estimates for PFS by treatment arm along with corresponding 95% confidence intervals. Cox proportional hazards models will also be used to assess influential factors on PFS both in the univariate and the multivariable settings.
Up to 5 years

Secondary Outcomes (3)

Incidence of adverse events (safety and tolerability)
Up to 30 days after last dose
Overall survival
Up to 5 years
Overall response rate (ORR)
Up to 5 years

Study Arms (2)

Arm A (temozolomide, WSD0922-FU)

EXPERIMENTAL

Patients receive temozolomide PO QD on days 1-5 of cycles 1-6 and WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease recurrence while on therapy and are planning to undergo tumor resection or stereotactic biopsy prior to starting alternative treatment continue receiving WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle until the time of surgery. Patients also undergo ECHO and MRI throughout the trial and undergo chest x-ray and collection of tissue samples on study. Patients may undergo optional collection of blood and/or cerebrospinal fluid (CSF) samples throughout the trial.

Procedure: Archive Sample RetrievalProcedure: Biospecimen CollectionProcedure: Chest RadiographyProcedure: Echocardiography TestDrug: EGFR/EGFRvIII Inhibitor WSD0922-FUProcedure: Magnetic Resonance ImagingDrug: Temozolomide

Arm B (temozolomide)

ACTIVE COMPARATOR

Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience disease recurrence while on therapy and are planning to undergo tumor resection or stereotactic biopsy prior to starting alternative treatment may initiate WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days until the time of surgery. Patients also undergo ECHO and MRI throughout the trial and undergo chest x-ray and collection of tissue samples on study. Patients may undergo optional collection of blood and/or CSF samples throughout the trial.